The following data is part of a premarket notification filed by Clinical Data, Inc. with the FDA for Envoy 500 Hdl; Cholesterol Reagent Kit (model# 55301), Calibrator Kit (model# 55118).
| Device ID | K071706 |
| 510k Number | K071706 |
| Device Name: | ENVOY 500 HDL; CHOLESTEROL REAGENT KIT (MODEL# 55301), CALIBRATOR KIT (MODEL# 55118) |
| Classification | Ldl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl |
| Applicant | CLINICAL DATA, INC. 1075 WEST LAMBERT ROAD Brea, CA 92821 -2944 |
| Contact | Wynn Stocking |
| Correspondent | Wynn Stocking CLINICAL DATA, INC. 1075 WEST LAMBERT ROAD Brea, CA 92821 -2944 |
| Product Code | LBS |
| CFR Regulation Number | 862.1475 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-06-21 |
| Decision Date | 2007-12-20 |
| Summary: | summary |